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The U.S. Food and Drug Administration (FDA) has granted approval for Xolair (Omalizumab) injection to treat immunoglobulin E (IgE)-mediated food allergy in certain adults and children aged 1 year and older. This approval marks a significant advancement in the management of allergic reactions, including the reduction of anaphylaxis risk, that may occur due to accidental exposure to one or more foods.
Developed by Genentech, Xolair was initially approved in 2003 for the treatment of moderate to severe persistent allergic asthma in specific patient populations. It is also approved to treat chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps in certain patients.
Dr. Kelly Stone, associate director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research, highlighted the significance of this approval, stating, “This newly approved use for Xolair will provide a treatment option to reduce the risk of harmful allergic reactions among certain patients with IgE-mediated food allergies.”
According to the Centers for Disease Control and Prevention (CDC), nearly 6% of people in the United States had a food allergy in 2021, with exposure to allergenic foods potentially leading to life-threatening allergic reactions, including anaphylaxis. Despite the absence of a cure for food allergy, treatment typically involves strict avoidance of allergenic foods and prompt administration of epinephrine in case of accidental exposure.
Xolair functions by binding to IgE, the antibody type responsible for triggering allergic reactions, and blocking its interaction with receptors. The safety and efficacy of Xolair in reducing allergic reactions in subjects with food allergies were demonstrated in a clinical study involving 168 pediatric and adult subjects allergic to peanut and at least two other foods.
During the study, subjects received Xolair or placebo treatment for 16 to 20 weeks. Results showed that a significant percentage of subjects treated with Xolair were able to tolerate doses of peanut, cashew, milk, or egg protein without experiencing moderate to severe allergic symptoms, compared to those who received placebo.
While Xolair demonstrated promising results in reducing allergic reactions, common side effects observed included injection site reactions and fever. The drug also comes with certain warnings and precautions, including the risk of anaphylaxis, malignancy, and abnormal laboratory tests.
Xolair received Priority Review and Breakthrough Therapy designations for this indication, highlighting the FDA’s recognition of its potential to address unmet medical needs. However, it is important to note that Xolair is not approved for the immediate emergency treatment of allergic reactions, including anaphylaxis.
The approval of Xolair for the treatment of IgE-mediated food allergy signifies a significant step forward in managing food allergies and reducing the risk of severe allergic reactions, offering hope to patients and their families.
